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Regulatory Affairs Manager

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Our client is a leading organization in the pharmaceutical industry, involved in various aspects such as product development, registration, production, and commercialization of pharmaceutical products, as well as offering pharmaceutical services. With a growing team of professionals, they are expanding to continue providing exceptional services to their clients. As part of this growth, they are currently seeking a Regulatory Affairs Manager.

Details

Pharmaceutical

randstad - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

As a Regulatory Affairs Manager, you will be responsible for preparing and managing regulatory submission dossiers for pharmaceutical products to secure registration in key markets, ensuring deadlines are met and collaborating with clients. You will coordinate variations according to guidelines and provide strategic input on formulation, process, and method development. Achieving milestones related to dossier goals is essential, as is maintaining communication with internal teams, stakeholders, and regulatory authorities. Additionally, you will draft reports for both internal and external use while actively participating in team discussions.

QTC logo icon what's needed

What you bring

You, as the ideal Regulatory Affairs Manager will recognise yourself in the following:

  • Minimum 3 years of experience performing various regulatory affairs duties including writing CMC part within a pharmaceutical company;
  • Thorough knowledge of EU and national regulations/guidelines in the field of regulatory affairs;
  • Solid understanding of compiling, updating, and amending registration dossiers, as well as electronic submission processes;
  • Proficiency in Word, Excel, and (preferably) Adobe Acrobat;
  • Detail-oriented, with strong planning, organizational skills, and results-driven mindset

QTC logo icon What we offer

What's in it for you

What we offer:

  • a challenging and responsible position
  • dynamic and growing organisation
  • competitive salary and benefits package

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